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Ron Travaglino Director

Ron Travaglino Director. Accommodating Patients’ Requests For Medical Treatment Without Allogeneic Blood. Bloodless Medicine and Surgery Defined. Use of New and Existing Techniques, Procedures, Technology, and Equipment to reduce or eliminate the need to use allogeneic (donor) blood.

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Ron Travaglino Director

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  1. Ron Travaglino Director

  2. Accommodating Patients’ Requests For Medical Treatment Without Allogeneic Blood

  3. Bloodless Medicine and Surgery Defined • Use of New and Existing Techniques, Procedures, Technology, and Equipment to reduce or eliminate the need to use allogeneic (donor) blood

  4. Englewood Hospital & Medical Center Bloodless Institute • Patients from 40 States in USA • Patients from 40 Countries • Major Cardiac, Orthopedic, Vascular, Neurological, Gynecological, Hepatic, Thoracic, Urologic Surgery • Hundreds of Transfers from Other Hospitals including those claiming to be “Bloodless” Centers

  5. Bloodless Medicine and Surgery - A Multidisciplinary Effort • Surgeons • Anesthesia Personnel • Nurses • Internists • Hematologists • Administrators • Ancillary Staff • Pharmacy • Lab • Blood Bank

  6. Englewood Hospital and Medical Center-Bloodless Institute • 200+ Physicians • Six dedicated staff members • Patient Intake and care coordination • Patient Education, Advance Directives • Preoperative patient preparation • Patient Advocacy • Four Medical Directors • Regular nursing, physician, staff education • Regular community education

  7. Bloodless Medicine and Surgery –Why? • Crisis in Blood Supply and Availability • Blood Borne Disease Risks • Patient refusal/reluctance • Cost Considerations

  8. Bloodless Medicine and Surgery - Why? • Patient’s choice* • Blood is a precious fluid • Increasing Elderly Population • By 2030, annual shortfall of 4 million units in USA • Less than 5% of eligible population donates in USA • Blood Transfusion is associated with Significant Cost

  9. Reasons That Support Bloodless Medicine and Surgery • Blood therapy is expensive-proven risks and hazards • Public health concerns • Shortage of blood nationally • Medical devices and pharmaceuticals facilitate bloodless care • No significant increase of morbidity and mortality • Overall decrease in healthcare costs • Enhances practical clinical experience • Growing patient population supplies data for more education • Supports patient’s rights and autonomy • Good economics

  10. Who are the Patients? • Religious Motivation • Primarily* Jehovah’s Witnesses • Non - Religious Motivation • Concern over blood safety • Personal/Family Member History of Problematic Transfusion • Vegetarians

  11. Jehovah’s Witnesses and Associates - World Population • 1985 - 7,792,109 • 1995 - 13,147,201 • 2000 - 14,872,086 • 2007 - 16,675,113

  12. Jehovah’s Witnesses • Do Not Refuse Medical Care - only blood transfusions • Refusal of Blood not a RIGHT TO DIE Issue • Actively Pursue Non Blood Medical Management

  13. Jehovah’s Witnesses Do Accept • Various Surgical, Medical, Anesthesia, Nursing Modalities to Conserve/Preserve Blood • All Other Types of Standard Medical Care

  14. Medical/Scientific Line of Reasoning Realistic consideration of physical Risks vs. Benefits Conscientious Line of Reasoning Thoughtful consideration of other Risks vs. Benefits (i.e. spiritual) Fractional Components

  15. Blood Fractions - Examples • ALBUMIN (EPO) • IMMUNE GLOBULINS • CLOTTING FACTORS (some) • CRYOPRECIPTATES • HEMOGLOBIN BASED PRODUCTS • More and More Available

  16. Making the Decisions - Medical Line of Reasoning • Blood Fractions are fundamental tools in hands of Physicians • Many “non blood” alternatives fit into these categories • Some used only in the face of imminent loss of life, so small risk of disease is tolerable

  17. Accommodating Patients…Legal and Ethical Principles • Bodily Self Determination • Upheld by US Supreme Court and State Courts • Right to Refuse Treatment • Special Considerations for Minors

  18. Risks of Blood Transfusions • Incompatibility • (ABO and other groups) • Infectious complications • Immunomodulatory • Resource availability • Risk to Benefit Ratio

  19. Blood Collection and Transfusion - US in 1999 • 13,225,000 allogeneic units collected • 12,020,000 allogeneic units transfused • 226,000 lost to screening (1.7%) • 787,000 outdated (5.9%) • 112/1709 (6.6%) of hospitals cancelled surgery because of no blood

  20. Transfusion Behavior (Survey) 1997 US physicians: 100 MD’s all ‘specialists’. At what Hb. would you be transfused? • Hb. of 9 gms/dl 0% • Hb. of 7 gms/dl +/-5% • Hg. of 5 gms/dl +/-14% • Lower? +/-19.5% • > 78% have Tx. Patients with Hb. ~9.0 gms • Role of guidelines in Transfusion Medicine Bifano et.al.

  21. Bloodless Institute & Risk Management • No Legal Cases or Consequences attributable to Bloodless Program • Patients sign Release of Liability Form on admission • No change in Hospital’s Liability Insurance Coverage

  22. Hospital Liability? • “The court allowed the plaintiff's negligence action against the hospital for not having given recipient notice of the danger of transfusions…. “ • Estate of Jane Doe v. Vanderbilt University, Inc. 1993

  23. Bloodless Care and Cost Savings • Cost of acquiring ONE unit of Packed Red Blood Cells is approximately $225 US* • TRUE cost much higher (transport, storage, administration, potential complications) • Study found allogeneic transfusions associated with $1000-$1500 US incremental Hospital costs

  24. Management of Anemia • Careful Evaluation and Diagnosis • Accurate History and Physical • Avoid and/or Manage Preoperatively if at all Possible Recombinant Human Erythropoietin (Epoetin Alfa)

  25. EPO DOSING REGIMEN 300-600 Units/Kilogram, from three to ten weeks before Surgery, Subcutaneously or Intravenously • Postoperative Bleeding • GI Bleeding • Oncology • Postpartum • GYN Bleeding

  26. Adjuvants to EPO • Folic Acid (1 mg/day) • Vitamin B-12 • Ascorbic Acid (500 mg/day) • Iron (Oral or Intravenous)

  27. Bloodless Medicine and Surgery - Intraoperative Surgical Management • Meticulous Hemostasis • Electrocautery • Laser Surgery • Argon Beam Coagulation • Tissue Adhesives • Cell Salvage

  28. Bloodless Medicine and Surgery - Anesthesia Management • Embolization • Positioning of patient • Hypotensive anesthesia • Induced hypothermia • ACUTE NORMOVOLEMIC HEMODILUTION • Aprotinin, DDAVP, Tranexamic acid, conjugated estrogens

  29. Iatrogenic Blood Loss Average ICU Patient can lose 1000 ml or more of blood PER WEEK from phlebotomy for laboratory testing

  30. Routine Blood Testing Routine Blood Tests are often UNECESSARY in Patients who refuse transfusion, or if no changes in clinical management will result from information obtained

  31. Transfusion  Immunomodulation Multiple studies show that transfusion is associated with increased risk of earlier cancer recurrence, lack of response to cancer treatment, and serious postoperative infection.

  32. SHOT - Serious Hazards Of Transfusions • 24 month study in UK and Ireland(1996-1998) • 424 hospitals surveyed • 39% (164) responded • Outcome measures • Death • “wrong blood” - “wrong patient” • acute and delayed transfusion reactions • Acute lung injury • Graft vs. host reaction • Purpura • Infections

  33. SHOT - Serious Hazards Of Transfusions • 366 major adverse events reported • 52% were due to “wrong blood to patient” • 22 total deaths • 3 - ABO • 12 - infections, 4 - bacterial*, 7- viral, 1 - malaria*

  34. When does a patient get transfused? • Really?

  35. Risks of blood transfusion( Per unit of blood U.S.A. ) • Minor allergic reactions 1:100 • Viral hepatitis (A,B,C,D,G) 1:50,000 • Hemolytic reactions 1:6,000 • Fatal hemolytic reactions 1:600,000 • HIV infection 1:420,000* • HTLV-I/II 1:200,000 • Bacterial infections 1:2,500 • Acute lung injury 1:500,000 • Anaphylactic shock 1:500,000 • Graft Vs. host disease Rare • Immunosuppression 1:1

  36. Viruses HIV-1,2 … HTLV-I,II Cytomegalovirus Epstein-Barr virus Parvovirus B19 Creutzfeldt-Jakob disease(CJD) TTV West Nile Spirochetes Treponema pallidum Borrelia burgdorferi Parasites Plasmodia Babesia microlti Trypanosoma crizi Toxoplasma gondii Leishmania donovani Bacteria Staphylococcus Salmonella Yersinia enterocolitica Infectious complications

  37. To all who received blood fromJanuary 1991 to December 1996in aNew York/New Jersey hospital Here is important information from the New York Blood Center for anyone who received a transfusion of red blood cells, platelets, or plasma in a New York or New Jersey hospital between January 1991 and December 1996. During that period, there may have been a problem with the way New York Blood Center performed testing of blood for viral infections. As a result, recipients of donated blood products during that period may face a potential risk of transfusion-transmitted infections, such as HIV and hepatitis.

  38. Risk versus Benefit • Known risks include disease transmission, reactions, immunomodulation • Benefit of blood unproven • Storage dramatically diminishes blood’s effectiveness as O2 carrier • Known risks outweigh perceived benefits

  39. To patient To physician To society Age-based? Diagnosis-based? What is Acceptable Risk?

  40. Blood Transfusion is Life Saving? • NO proof except when used as volume replacement in resuscitation • There are safer, equally effective alternatives such as saline and colloids • NO trials that demonstrate better survival from blood transfusion

  41. NJ Institute of Bloodless Medicine and Surgery Patient Totals • Year # pt Mortality • 1994 510 0 • 1995 650 1 • 1996 1,057 1 • 1997 1,267 1 • 1998 1,949 1 • 1999 2,540 1 • 2000 2,751 1 • 2001 3,047 1

  42. Range of Low Hgb. Survivors • 5 patients <2.0 gms* • 16 patients 2.0 - 3.0 gms • 25 patients 3.0 - 4.0 gms • 69 patients 4.0 - 5.0 gms *(4 @ 1.7 gms – 1 @ 1.3 gms!) 11/30/07

  43. Clinical Outcomes • Our data only • January 1997 to June 1999 • Colectomy • Total Hip Arthroplasty • Total Knee Arthroplasty • Abdominal Hysterectomy

  44. Increased Length of Hospital Stay and CostsTransfused vs. Non Transfused PatientsSelected Surgical ProceduresEnglewood Hospital and Medical Center, NJJanuary 1997 – June 1999 Procedure Average ^ LOS Average ^ Cost (US Dollars) Colectomy 1.86 $8,300. Total Hip Arthroscopy 0.43 $990. Total Knee Arthroscopy 0.43 $797. Abdominal Hysterectomy 1.19 $6,723.

  45. Resources • www.bloodlessmed.com • www.sabm.org

  46. COMMUNICATIONCOOPERATIONNOT CONFRONTATION

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